Fresenius Kabi Link Agilia Instructions For Use Manual
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Fresenius Kabi Link Agilia Instructions For Use Manual

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Summary of Contents for Fresenius Kabi Link Agilia

  • Page 1 Link Agilia Instructions for use...
  • Page 2 Local contacts for servicing Complete this box with your contacts: 5592-5_nu_Link_agilia_INT...

  • Page 3: Table Of Contents

    Table of contents INTRODUCTION 1.1 S ....................5 COPE 1.2 I ....... 6 NSTRUCTIONS FOR USE DESCRIPTION OF SYMBOLS 1.3 I ..................6 NTENDED USE DEVICE DESCRIPTION 2.1 L ............... 9 INK SYSTEM DEFINITION 2.2 F ..................10 RONT VIEW 2.3 S .............
  • Page 4 11 ORDERING INFORMATION 11.1 L ..............34 GILIA PACKAGING 11.2 A ..................34 CCESSORIES 12 TECHNICAL SPECIFICATIONS 12.1 T ................. 36 ECHNICAL DATA 12.2 E ............37 LECTROMAGNETIC COMPATIBILITY 13 WARRANTY 13.1 G ..........40 ENERAL CONDITIONS OF WARRANTY 13.2 L ................

  • Page 5: Introduction

    Introduction The Link Agilia rack system is intended to power up to 4, 6 or 8 connected Agilia pumps, thus reducing the number of power cables and organizing infusion pumps at the bedside. The use of Link Agilia rack does NOT change the standalone pump intended use.

  • Page 6: Instructions For Use: Description Of Symbols

    Give a particular attention to the texts which are highlighted by a symbol. Link Agilia rack system is intended to power Agilia IV pumps and organize in a logical way bedside infusion pumps mounting.

  • Page 7: Intended Patient Population

    Agilia infusion pumps. 1.3.3 Intended user population Warning:  Link must only be used by qualified and trained medical staff.  In order to be trained, please contact your Fresenius Kabi representative or a certified trainer. 1.3.4 Intended conditions of use 1.3.4.1...
  • Page 8 1.3.4.2 Use environment Link is intended to be used in hospital intensive (ICU) and Critical Care Units (CCU), Operating Rooms (OR) and post-operative care (PACU), emergency care (ED), Neonatal Intensive Care Unit and Neonatal Care Unit (NICU, NCU) and general care units. Information: ...

  • Page 9: Device Description

    2.1 Link system definition The Link Agilia system is composed of the following elements:  1 Link Agilia rack able to stack 4, 6 or 8 Agilia IV pumps with a power cord.  Up to 8 Agilia IV pumps with their respective accessories, disposables and documents.

  • Page 10: Front View

    2.2 Front view Legend: Pump lock / release mechanism lever Pump shelf Pump power inlet Plastic bumper Symbol Location Symbol description On pump lock / release Pushing area to lock and unlock mechanism lever pumps from Link 5592-5_nu_Link_agilia_INT...

  • Page 11: Side View With Power Plug

    Symbol Location Symbol description Warning: Do not remove the rack from pole or rails if IV pumps are connected. The rack is heavy when installed On right and left sides with IV pumps. Remove IV pumps first, before removing the rack from poles or rails.

  • Page 12: Back View

    2.4 Back view Legend: Upper fixing clamp Lower fixing clamp Symbol Location Symbol description Each locking Warning: Please consult mechanism and accompanying documents labels on both sides On the back of the Warning: Clamps must be device mounted outside this area 5592-5_nu_Link_agilia_INT...

  • Page 13: Device Labelling

    Device labelling 3.1 Device identification label Symbol Description Product reference / part number Product serial number Input terminal - connector Output terminal - connector Electrical fuses Alternating Current (AC) Protection against leakage current; type B applied part IP22 Index of protection against splashing liquids Not to be used in residential area Obligation for the user to refer to the Instructions for use...

  • Page 14: Packaging Symbols

    3.2 Packaging symbols Symbol Description Fragile, handle with care This way up Keep away from rain Temperature limitation Humidity limitation Atmospheric pressure limitation General symbol for recyclable material Eco packaging symbol Information:  Please refer to the 'Storage and transport conditions' section for additional information on temperature, pressure and humidity limitations.

  • Page 15: Switching On And Off

    Switching on and off The device switches ON when the power cord is plugged into mains power supply. Information:  There is no ON/OFF button on the Link. 5592-5_nu_Link_agilia_INT...

  • Page 16: Link And Pumps: Installation And Removal

     Please refer to the 'Ordering information' section for additional information. The Link packaging contains the following elements:  1 Link Agilia for 4, 6 or 8 IV pumps.  1 country kit including:  1 'Instructions for use' manual.

  • Page 17: Link Preparation

    5.2 Link preparation Fixing clamp installation and adjustments Warning:  Position rack clamps to be compatible with your pole or rails mounting system.  Make sure that the clamps are firmly fixed to avoid movement.  Maintain sufficient distance between the clamps to assure stable installation of the Link.

  • Page 18: Link Installation

    5.3 Link installation Warning:  Do not install Link if IV pumps are already installed on it.  Link is designed to be installed on a fixed pole and fixed rails or any recommended accessories. Please refer to the 'Ordering information' section for additional information.
  • Page 19 The Link 4, 6 and 8 are designed to be mounted on new MultiChannel Rolling Stand (Part number Z073160) and Twin Link Rolling Stand (Part number Z073170). For additional information about how to install the Link Agilia on Rolling stand, please consult the related instructions for use. 5.3.3 Switching on the rack Caution: ...

  • Page 20: Pump Installation And Removal

    Caution:  Do not try to connect IV pumps other than those recommended.  The Link Agilia rack has 4, 6 or 8 outlets, to power Agilia pump devices. These outlets are connected to a functional earth.  An internal switch cuts power on empty positions.This system does not guarantee protection against electric strokes in all cases, so usual caution must be applied.
  • Page 21 5.4.2 Installing an IV pump Warning:  When used with volumetric pumps and IV bags, respect the installation instructions as detailed in the pump instructions for use (prefer the lowest positions for volumetric pumps).  Do not force during pump installation.
  • Page 22 3. Push the pump firmly so that the locking mechanism secures the pump (be sure to hear the 'click') as indicated on the auto locking mechanism. Legend: Pump locking mechanism 4. When the rack is powered by the mains power supply, check on the pump display that the power display light is ON and listen to...
  • Page 23 5.4.3 Removing an IV pump when infusion is ended In order to remove an IV pump, proceed as follows: Warning:  Do not force during pump removal. If you have to force excessively, do not use the devices and contact your After-Sales Service.

  • Page 24: Remove The Link From Fixed Pole, Fixed Rails Or Rolling Stand

    5.5 Remove the Link from fixed pole, fixed rails or Rolling stand Warning:  Never remove the rack from the pole or rails if IV pumps are installed.  When installed on a rolling stand, please refer to the rolling stand instructions for use.

  • Page 25: Recommendations For Cleaning

    6.3 Recommended cleaning agents Prefer to use ALCOHOL BASED SPRAY DILUTED UP TO 80% to clean the device. Please contact the appropriate service of your hospital or your Fresenius Kabi sales organization for further details. 5592-5_nu_Link_agilia_INT...

  • Page 26: Cleaning Guidelines And Protocol

    6.4 Cleaning guidelines and protocol The device is part of the patient's immediate environment. It is advisable to clean and disinfect the device's external surfaces regularly and especially before connecting a new patient and before any maintenance operation in order to protect the patient and the operator.

  • Page 27: Device Storage And Transport

     Link must be cleaned and disinfected prior to storage. Please refer to the 'Recommendations for cleaning' section in this document. For transport, contact Fresenius Kabi to have packaging shipped to your facility. Clean and disinfect the device and then pack it in the provided packaging.

  • Page 28: Installing The Device After Storage

    7.4 Installing the device after storage Information:  We recommend that the 'Link Quick check protocol' is performed when the device is installed after transport and before being used on a new patient. 5592-5_nu_Link_agilia_INT...

  • Page 29: Link Quick Check Protocol

    Link Quick check protocol The following protocol provides the user with a quick check guide to ensure that Link Agilia system is functional. Warning:  It is recommended that this protocol be applied after installation and before use of the device on a new patient.
  • Page 30 The device is declared functional ONLY if all tests are   CONFORM. Note: if one or more tests do not conform, please contact the appropriate service, department or our After-Sales Service or our Customer service. Operator name and signature: Date: ___ / ___ / ___ 5592-5_nu_Link_agilia_INT...

  • Page 31: Troubleshooting And Messages

    This section provides information to perform a first troubleshooting of the Link Agilia. Information:  For additional information about issues and troubleshooting, please contact your biomedical department or Fresenius Kabi After-Sales Service. Refer to page 2 for contacts. Issue description Recommended action Rack is not stable when mounted ...

  • Page 32: Servicing

    After-Sales Service or our Customer service. Information:  If the device must be sent for servicing, contact Fresenius Kabi to have packaging shipped to your facility. Clean and disinfect the device and then pack it in the provided packaging and ship to Fresenius Kabi.

  • Page 33: Quality Control

    Link Agilia every 12 months. A regular quality control (not included in the guarantee) consists of various inspection operations listed in the technical manual. Please refer to the technical manual or contact your Fresenius Kabi After- Sales Service. Information: ...
  • Page 34 11.1 Link Agilia packaging 11.1.1 Link Agilia Link Agilia is available in 3 versions: Link 4 Agilia, Link 6 Agilia and Link 8 Agilia. Please contact your Fresenius Kabi sales representative for ordering. 11.1.2 Country kit Country kit is composed of a power cord and an 'Instructions for use' document translated into local languages.

  • Page 35: Mounting Systems

     To avoid any fall and potential harms, follow carefully the compatibility chart below to ensure that Link 4, 6 and 8 are installed on the appropriate rolling stand. Compatibility chart between Link 4/6/8 and Fresenius Kabi rolling stands: Fresenius Kabi rolling stand part number...

  • Page 36: Technical Specifications

    Technical specifications 12.1 Technical data 12.1.1 Dimensions - Weight H/W/D 720 mm (28.35 in) x 184 mm (7.24 in) x 163 mm (6.42 in) Link 4 Weight 3.6 kg (7.94 lb) H/W/D 1010 mm (39.76 in) x 184 mm (7.24 in) x 163 mm (6.42 in) Link 6 Weight 4.7 kg (10.36 lb)

  • Page 37: Compliance With Standards

    12.2.1 Table 1 - Guidance and manufacturer's declaration - Electromagnetic Emissions Warning:  The Link Agilia rack system is intended to be used in the electromagnetic environment specified below.  The customer or the user of the Link Agilia rack should ensure that it is used in such an environment.
  • Page 38 12.2.2 Table 2 - Guidance and manufacturer's declaration - Electromagnetic Immunity Warning:  The Link Agilia rack system is intended to be used in the electromagnetic environment specified below.  The customer or the user of the Link Agilia rack should ensure that it is used in such an environment.
  • Page 39 12.2.3 Table 4 - Guidance and manufacturer's declaration - Electromagnetic Immunity Warning:  The Link Agilia rack system is intended to be used in the electromagnetic environment specified below.  The customer or the user of the Link Agilia rack should ensure that it is used in such an environment.

  • Page 40: General Conditions Of Warranty

    Warranty 13.1 General conditions of warranty Fresenius Kabi guarantees that this product is free from defects in material and workmanship during the period defined by the accepted sales conditions and the accessories. 13.2 Limited warranty To benefit from the materials and workmanship guarantee from our...

  • Page 41: Recycling And Disposal

    They must be collected separately and disposed of according to local regulations. Information:  For further information pertaining to waste processing regulations, contact your local Fresenius Kabi organisation or the local distributor. Packaging description:  Packaging weight: Link 4: Approximately 1.2 kg.

  • Page 42: Glossary Of Terms

    Glossary of terms Term Description Ampere Alternating Current Range of infusion pumps manufactured by Fresenius Agilia Kabi Ampere hour Critical Care Unit CISPR Special International Committee on Radio Interference Electrocardiogram Emergency Department Electroencephalogram Electromagnetic compatibility Electrostatic Discharge H/W/D Height / Width / Depth Hertz International Electrotechnical Commission Instructions for Use...
  • Page 43 Term Description Serial Number Test specification level Volt Volt Ampere Vigilant Drug'Lib Dose Error Reduction Software (DERS) for IV pumps 5592-5_nu_Link_agilia_INT...
  • Page 44 Fresenius Kabi. The software may not be copied except for archival purposes or for backup, or replacement of defective media. Agilia® is a registered trademark by Fresenius Kabi in selected countries. Revision date: September 2015 Fresenius Kabi AG 61346 Bad Homburg...
  • Page 45 5592-5_nu_Link_agilia_INT...

This manual is also suitable for:

Link4 agiliaLink6 agiliaLink8 agilia

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